Colon Cancer Surgery in the Aged; Postoperative Outcome, Functional

Status Completed

Clinical Trial Summary

Patients aged > 80 years represent an increasing proportion of colon cancer diagnoses. It is important to have relevant and trustable data concerning elderly colorectal cancer patients surgery and postoperative morbidity, functional ability, life quality and survival numbers. With possibly compromised health status and functional decline the benefits of surgical management and outcomes can diminish life quality and overall survival. With proper patients selection, preoperative health evaluation and thus patient information, colorectal cancer surgery can be performed with lower morbidity and mortality rates with comparative survival numbers. The aim of this prospectively collected, observational study is to acquire data from colorectal cancer surgery in aged over 80 years and perform statistical analysis of the preoperative risk factors affecting postoperative morbidity, functional recovery, mortality and overall survival.

Clinical Trial Description

9 Finnish hospitals including three university hospitals participate in the study. The data is collected from the hospitals using a specially designed and secure web application (RedCap). The preoperative patients' data include comorbidities, clinical frailty scale (CFS) and functional status, postoperative surgical and medical outcomes and survival data. The patient questionnaire is based on the G-8 geriatric screening tool and MNA-short form. The questionnaire is filled out preoperatively and 1, 3, 6 and 12 months postoperatively. The patient data concerning procedures is collected from the hospitals prospectively recording data. Mortality data on causes of death are obtained from Statistics Finland. All colon cancer patients aged over 80 years with curative disease (stage I-III) are included. Patients with metastatic disease or severe Alzheimer disease are excluded. They are treated either non-operatively or with curative resection or palliative procedure. Patients fill out the approval form. The study is acknowledged by the ethics committee of the participating hospitals. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03904121
Study type	Observational [Patient Registry]
Source	Tampere University Hospital
Contact
Status	Completed
Phase
Start date	April 1, 2019
Completion date	March 31, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Colon Cancer Surgery in the Aged; Postoperative Outcome, Functional Recovery and Survival.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms